Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

March 30, 2009 updated by: G. Hatzikosta General Hospital

Laparoscopic Nissen Fundoplication Combined With Posterior Gastropexy in Surgical Treatment of Gastroesophageal Reflux Disease

Laparoscopic Nissen Fundoplication has established itself as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (GERD). Postoperative paraesophageal herniation has incidence ranges up to 7% in the immediate postoperative period. This randomized controlled study was scheduled to investigate the role of the posterior gastropexy, in combination with laparoscopic Nissen fundoplication, in prevention of paraesophageal herniation and improvement of postoperative results, in surgical treatment of GERD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Epirus
      • Ioannina, Epirus, Greece, 45001
        • G. Hatzikosta General Hospital Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years
  • Indications for surgical treatment of GERD
  • ASA I, II

Exclusion Criteria:

  • ASA III, IV
  • Previous gastric procedures
  • Conversion to open procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Nissen
Laparoscopic Nissen Fundoplication
Procedure: Nissen
Laparoscopic Nissen Fundoplication
ACTIVE_COMPARATOR: Gastropexy
Procedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy
Procedure: Nissen
Laparoscopic Nissen Fundoplication
Procedure: Gastropexy
posterior gastropexy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD
Time Frame: 9-94 months postoperatively
9-94 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G. Hatzikosta General Hospital

Investigators

  • Study Chair: Evangelos C. Tsimoyiannis, M.D. chairman, G. Hatzikosta General Hospital, Ioannina, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

March 30, 2009

First Submitted That Met QC Criteria

March 30, 2009

First Posted (ESTIMATE)

March 31, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2009

Last Update Submitted That Met QC Criteria

March 30, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH-1948-02
  • GHDS-12345-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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